Inclusion of Older Adults in NIH-funded Phase III Clinical Trials

Drs. Jaron Lockett and Samir Sauma (from NIA’s Office of Planning, Analysis, & Evaluation), Dr. Barbara Radziszewska (from NIA’s Division of Geriatrics and Clinical Gerontology) and Dr. Marie A. Bernard (NIA’s Deputy Director), authored a recent article on the Inclusion of Older Adults in NIH-funded Phase III Clinical Trials. This article, published in the Journal of the American Geriatrics Society, describes an analysis conducted by the NIA on the number of older adults included as participants in NIH-funded phase III clinical trials between 1965 and 2015. The data reflect a disproportionate underrepresentation of older adults in these clinical studies, through both explicit and implicit exclusion criteria and suggest that outcomes of the trials may not be fully generalizable to the population of older adults. Despite these findings, the authors are hopeful that new guidelines on the inclusion of individuals across the lifespan may lead to a greater representation of this population in future studies. The new policy, which went into effect recently, mandates that all applications for NIH-funded clinical studies received after January 25, 2019 include research participants across the lifespan, including children and older adults (unless there is a scientific justification to exclude them). The new policy also requires investigators to provide data on participant age at enrollment in progress reports. The NIH is optimistic that these changes will enhance recruitment across all ages and yield trial results that are more generalizable to the population. The ongoing efforts to revisit and revise the NIH-wide inclusion policy, as mandated in the 21st Century Cures Act passed in 2016, were discussed in a Viewpoint Essay published in the Journal of the American Medical Association in October 2018; this article was co-authored by Dr. Bernard with Dr. Janine Clayton (Director of the NIH’s Office of Research on Women’s Health), and Dr. Michael Lauer (NIH’s Deputy Director for Extramural Research).